I. Subject and conditions of application
The filing subject is usually a medical device manufacturer or a commercial enterprise. These enterprises need to have corresponding production or business qualifications and meet the basic requirements of the state for medical device enterprises. In addition, enterprises also need to ensure that the medical devices put on record belong to the second category of medical devices, that is, medical devices with moderate risks that need strict control and management to ensure their safety and effectiveness.
Second, the filing materials preparation
Enterprises need to prepare a series of related materials when applying for the second class medical devices. These materials include, but are not limited to:
1. Medical device registration certificate or filing certificate;
2. Sample product manuals and labels;
3. Product quality inspection report;
4. Qualification certification documents of the production enterprise;
5. Qualification certificate of the operating enterprise (if applicable);
6. Other relevant certification materials.
Enterprises need to ensure that these materials are true, complete and accurate, and organize the submission as required.
Third, filing procedures.
The filing process usually includes the following steps:
1. The enterprise logs into the filing system designated by the State Administration of Pharmaceutical Products, fills in the filing information and uploads relevant materials;
2. The pharmaceutical supervisory and administrative department shall examine the materials submitted by the enterprise, and may require the enterprise to supplement or modify the materials when necessary;
3. After the approval, the drug regulatory authorities will issue filing vouchers and publicize the filing information on the designated platform;
4. After the enterprise has obtained the record certificate, it can carry out the corresponding medical device production or business activities.
In the process of filing, enterprises need to pay close attention to the notices and requirements of the drug regulatory authorities to ensure the smooth filing work.
Fourth, supervision after filing.
After the filing is completed, the drug regulatory authorities will continue to supervise the medical devices that have been filed. This includes supervision and inspection of production or business activities of enterprises, sampling inspection of product quality, etc. If illegal acts or product quality problems are found in the enterprise, the regulatory authorities will investigate and deal with them according to law.
To sum up:
The second-class filing requirements of medical devices involve the subject and conditions of filing, the preparation of filing materials, the filing process and the supervision after filing. Enterprises need to file in strict accordance with relevant regulations to ensure the safety, effectiveness and compliance of medical devices. At the same time, the regulatory authorities also need to strengthen supervision to ensure the safety of public use of machinery.
Legal basis:
Regulations on the supervision and administration of medical devices
Article 8 provides that:
The state implements classified management of medical devices according to the degree of risk. The catalogue of Class I medical devices that meet the requirements of these Regulations and the classified catalogue of Class II domestic medical devices shall be formulated and adjusted by the US Food and Drug Administration in the State Council. Those who meet the management requirements of Class III medical devices stipulated in these Regulations shall be examined and approved, and a medical device registration certificate shall be issued.
Article 14 stipulates:
Where the design, raw materials, production technology, scope of application and usage of the registered Class II and Class III medical devices have substantially changed, which may affect the safety and effectiveness of the medical devices, the registrant shall apply to the original registration department for change of registration; Non-substantial changes do not affect the safety and effectiveness of medical devices, and changes shall be filed with the original registration department.
Measures for the administration of medical device registration
Article 5 provides that:
Medical device registration is a process in which the food and drug supervision and administration department systematically evaluates the safety and effectiveness research and results of medical devices to be listed according to the application and legal procedures of medical device registration applicants, so as to decide whether to approve their applications.